MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-08-07 for BACT/ALERT MP BLOOD CULTURE BOTTLE 259797 manufactured by Biomerieux, Inc..
[923169]
Based on information supplied initially, this complaint of a false negative was determined to be not reportable. Visual examination of the bottles indicated turbidity and growth. The lowernstein-jensen slants confirmed the samples were positive. Upon further investigation initiated by biomerieux, inc. , a different issue emerged concerning the algorithms used. This incident is now determined to be reportable. Following review of the user's database, it was determined that bottles barcode configuration parameters had been modified so that algorithms were assigned to the bact/alert blood culture bottle that do not conform to the current algorithm implementation for bact/alert plastic bottles. Also, a modification was made for the barcode prefix, probably to facilitate the use of barcodes other than those supplied by biomerieux. Incorrect algorithms may result in incorrect results.
Patient Sequence No: 1, Text Type: D, B5
[8105755]
An investigation has been opened on this mdr. Customer was contacted with instructions on how to verify the algorithms and to set the correct algorithms for plastic bottles. Global customer service also resent the field corrective action/amendment which had addressed the issue in the past. It is not known when, or by whom, the changes in the settings were made. Necessary medical treatment was not delayed or withheld because of the test result from the instrument. User's database was reviewed. Results and conclusions: algorithms parameters incorrectly modified, causing incorrect readings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2008-00004 |
| MDR Report Key | 1106975 |
| Report Source | 06 |
| Date Received | 2008-08-07 |
| Date of Report | 2008-08-08 |
| Date of Event | 2008-05-22 |
| Date Mfgr Received | 2008-01-16 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2009-09-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH FRITZ |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202682 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT MP BLOOD CULTURE BOTTLE |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2008-08-07 |
| Catalog Number | 259797 |
| Lot Number | 1017261 |
| Device Expiration Date | 2008-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-07 |